Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Docetaxel
Lipid Suspension (DLS) for Injectionof Intas Pharmaceuticals Limited, India in Non-Small
Cell Lung Cancer patients: Patients with histopathologically / cytologically confirmed
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient willing and able to give informed consent to participate in the study. 2. Male and Female patients >=18 years and 3. Patient with histologically/cytologically confirmed locally advanced or metastatic NSCLC after platinum therapy failure. 4. Patient should have at least one measurable lesion as per RECIST 1.1. 5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function as defined by the following parameters -Bone marrow function-ANC greater than 1500/mm3, Platelet count greater than 100,000/mm3. Hemoglobin Greater than 9.0 g/dL. -Renal function- Serum Creatinine -Hepatic function- Serum Bilirubin -LVEF- > 50%. 6. Patient should be able to comply with study procedures in the opinion of the investigator. 7. Patient with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) 8. Patient with Life expectancy more than six months 9. Serum pregnancy test at screening and urine pregnancy test on Day 1(before dosing) of each cycle must be negative. 10. Male or Female patients or their partner must agree to use effective measures of contraception during the study. (It is investigatorâ??s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.)
Exclusion criteria
Exclusion criteria: 1. Patient with the history of hypersensitivity reactions to Taxanes or any other component of formulation. 2. Chronic treatment with systemic steroids or another immunosuppressive agent or patient with severely immunocompromised state. 3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections). 4. Major surgery within 4 weeks prior to dosing or planned major surgery. 5. Patient treated with radiotherapy/and adjuvant chemotherapy within 30 days prior to screening 6. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis). 7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic,renal, hematologic, gastrointestinal, endocrine, immunologic,dermatologic,neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results. 8. Patients with hepatitis B or hepatitis C infection or known case of HIV infection. 9. Pregnant or breast-feeding patients. 10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 as defined by NCI CTCAE 4.03 criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Docetaxel Lipid Suspension for Injection 20/80 mg/vial, Manufactured by Intas Pharmaceuticals Limited, India in the patients with Non-Small Cell Lung Cancer.Timepoint: 6 Cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Docetaxel Lipid Suspension for Injection 20/80 mg/vial, Manufactured by Intas Pharmaceuticals Limited, India in Non-Small Cell Lung Cancer patients.Timepoint: 6 Cycles | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Lambda Therapeutic Research Ltd
Outcome results
None listed